URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)— 510(k) K971485

Name: FDA 510(k) clearance K971485
Creator: U.S. Food and Drug Administration
Published: 1997-05-27

Substantially Equivalent

Trace America, Inc.

FDA 510(k) clearance K971485 for URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), Substantially Equivalent on 1997-05-27. Applicant: Trace America, Inc.. Device class: 1.

Clearance details

Applicant: Trace America, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1997-04-23
Decision date: 1997-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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